MATCHING-ADJUSTED INDIRECT COMPARISON: ROZANOLIXIZUMAB VERSUS NIPOCALIMAB IN GENERALIZED MYASTHENIA GRAVIS
Author(s)
April Betts, PhD1, Urjashwal Vidhata, M.Sc2, Vikalp Maheshwari, PGDM2.
1UCB, Slough, United Kingdom, 2Parexel International, Hyderabad, India.
1UCB, Slough, United Kingdom, 2Parexel International, Hyderabad, India.
OBJECTIVES: As there are no head-to-head trials comparing FcRn inhibitors in generalized myasthenia gravis (gMG), this study assessed the comparative efficacy of rozanolixizumab (7 mg/kg; 10 mg/kg) versus nipocalimab using an anchored matching-adjusted indirect comparison (MAIC).
METHODS: A systematic literature review identified phase 3 trials for rozanolixizumab (MycarinG) and nipocalimab (VIVACITY-MG3). Feasibility was assessed by comparing eligibility criteria and baseline characteristics. To align eligibility with VIVACITY-MG3, MycarinG individual patient data were restricted to baseline MG-ADL score ≥6, then reweighted to match VIVACITY-MG3 aggregate baseline characteristics. Anchored treatment effects were estimated versus placebo within each trial and contrasted across trials as mean differences for MG-ADL change from baseline (CFB) and odds ratios (ORs) for MG-ADL response (≥2-point improvement). Outcomes were evaluated at common timepoints: MG-ADL CFB at Week 6 and MG-ADL response at Week 1 or 2.
RESULTS: After sub-setting and weighting on prespecified covariates, overlap diagnostics supported reweighting. Effective sample size remained high (ESS=85) with low incidence of extreme weights (<0.1 or >5), indicating stable estimation. In base-case analyses, both rozanolixizumab doses showed broadly comparable efficacy versus nipocalimab, with numerical advantages but no statistically significant differences. The anchored MAIC for MG-ADL CFB at Week 6 favoured rozanolixizumab versus nipocalimab: 10 mg/kg −1.56 (95% CI −2.91, −0.21) and 7 mg/kg −2.08 (95% CI −4.19, 0.02). Odds of MG-ADL response at Week 1 or 2 also favoured rozanolixizumab versus nipocalimab: 10 mg/kg OR 2.51 (95% CI 0.70, 8.95) and 7 mg/kg OR 3.53 (95% CI 0.93, 13.35). Findings were directionally consistent across prespecified sensitivity analyses.
CONCLUSIONS: With adequate overlap and stable weighting, this anchored MAIC presents similar efficacy for rozanolixizumab versus nipocalimab, with numerical benefits for rozanolixizumab across outcomes. Residual confounding from unmeasured effect modifiers cannot be excluded.
METHODS: A systematic literature review identified phase 3 trials for rozanolixizumab (MycarinG) and nipocalimab (VIVACITY-MG3). Feasibility was assessed by comparing eligibility criteria and baseline characteristics. To align eligibility with VIVACITY-MG3, MycarinG individual patient data were restricted to baseline MG-ADL score ≥6, then reweighted to match VIVACITY-MG3 aggregate baseline characteristics. Anchored treatment effects were estimated versus placebo within each trial and contrasted across trials as mean differences for MG-ADL change from baseline (CFB) and odds ratios (ORs) for MG-ADL response (≥2-point improvement). Outcomes were evaluated at common timepoints: MG-ADL CFB at Week 6 and MG-ADL response at Week 1 or 2.
RESULTS: After sub-setting and weighting on prespecified covariates, overlap diagnostics supported reweighting. Effective sample size remained high (ESS=85) with low incidence of extreme weights (<0.1 or >5), indicating stable estimation. In base-case analyses, both rozanolixizumab doses showed broadly comparable efficacy versus nipocalimab, with numerical advantages but no statistically significant differences. The anchored MAIC for MG-ADL CFB at Week 6 favoured rozanolixizumab versus nipocalimab: 10 mg/kg −1.56 (95% CI −2.91, −0.21) and 7 mg/kg −2.08 (95% CI −4.19, 0.02). Odds of MG-ADL response at Week 1 or 2 also favoured rozanolixizumab versus nipocalimab: 10 mg/kg OR 2.51 (95% CI 0.70, 8.95) and 7 mg/kg OR 3.53 (95% CI 0.93, 13.35). Findings were directionally consistent across prespecified sensitivity analyses.
CONCLUSIONS: With adequate overlap and stable weighting, this anchored MAIC presents similar efficacy for rozanolixizumab versus nipocalimab, with numerical benefits for rozanolixizumab across outcomes. Residual confounding from unmeasured effect modifiers cannot be excluded.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO180
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Neurological Disorders, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)